# FDA 483 - Serumwerk Bernburg AG - June 14, 2024

Source: https://www.keypedia.com/records/483/serumwerk-bernburg-ag/40d5225a-83c6-40a3-9a3d-b8de6c494fa7

> FDA 483 for Serumwerk Bernburg AG on June 14, 2024. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Serumwerk Bernburg AG
- Inspection Date: 2024-06-14
- Product Type: veterinary
- Office Name: Center for Veterinary Medicine
- Summary: Serumwerk Bernburg AG, an Active Pharmaceutical Ingredient (API) manufacturer in Bernburg (Saale), Germany, received a Form 483 with two observations. The inspection revealed failures in thoroughly investigating out-of-specification API batches and a lack of established written specifications and control mechanisms for laboratory stability chamber excursions. These issues indicate deficiencies in quality control and manufacturing process oversight.

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.keypedia.com/companies/serumwerk-bernburg-ag/b9464537-0d65-402a-a6cd-1a4d4b830a5b

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4